Device Classification Name |
device, acupressure
|
510(k) Number |
K142471 |
Device Name |
Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip |
Applicant |
Pressure Point Inc. |
936 Green Meadow Drive |
Tinton Falls,
NJ
07724
|
|
Applicant Contact |
Joseph DiLustro |
Correspondent |
Emergo Group |
816 Congress Avenue, Suite 1400 |
Austin,
TX
78701
|
|
Correspondent Contact |
Julie Powell |
Classification Product Code |
|
Date Received | 09/03/2014 |
Decision Date | 12/01/2014 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|